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FDA 510(k)

Dendrite Imaging System

K-Number: K253303 · 2025-11-28

ApplicantDendrite Imaging, Inc.
Decision Date2025-11-28
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dendrite Imaging System is a medical device manufactured by Dendrite Imaging, Inc.. It received FDA 510(k) clearance on 2025-11-28 under approval number K253303. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dendrite Imaging System?

Dendrite Imaging System is a medical device that received FDA 510(k) clearance on 2025-11-28. It is manufactured by Dendrite Imaging, Inc.. The 510(k) number is K253303.

When was Dendrite Imaging System approved by the FDA?

Dendrite Imaging System received FDA 510(k) clearance on 2025-11-28, under approval number K253303.

What company makes Dendrite Imaging System?

Dendrite Imaging System is manufactured by Dendrite Imaging, Inc..

What is the FDA product code for Dendrite Imaging System?

The FDA product code for Dendrite Imaging System is QDG.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: QDG)

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Official Source

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